Category

Description

Job Description

Conducts and documents Pre-Study Visits (PSVs), Study Initiation Visits (SIVs)/Qualification Visits (QVs), Monitoring Visits (MV) and Closedown Visits (CV) as per SOPs
Monitor and report on Investigators adherence to approved protocol/amendments and on study conduct at each study site
Ensure that the Investigator maintains all essential documents and that study related documents, including but not limited to source documents and case report forms, are complete and accurate
Conduct telephone calls to investigator sites to evaluate potential patient eligibility and enrolment, and to follow-up on any outstanding issues
Assist with investigator meetings through the preparation, assembly and shipment of training materials
Co-ordinate the collection of essential documentation in accordance with ICH/GCP
Identify, document and report SAEs according to ICH/GCP guidelines and local regulatory requirements, within required timelines and follow-up as required
Conduct final IMP reconciliation, and arrange return of unused IMPs to the sponsor
Be responsible for monitoring and maintaining IMP accountability at investigator sites
Prepare site visit reports and status reports, document site actions in follow up letters/e-mail
Assist Project Manager/CRA Manager with establishing and implementing the query resolution process
Gain an in-depth understanding of the study protocol, CRF and related procedures
Develop good working relationships with investigator site personnel and provide support, training and motivation
TMF filing and review, as required
Responsible for filing of documentation regarding designated sites
Adapt protocols/informed consent forms to country specific requirements
Develop/implement project specific monitoring tools and tracking forms under the direction of the Project Manager/CRA Manager

Qualifications

Educated to degree level or equivalent in a scientific field
Proven CRA experience, preferably within a CRO or a pharma company

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